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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A two generation reproductive toxicity study was conducted in gerbils to assess the effects of dietary exposure to 8.75% w/w palm kernel oil (PO).
Adult Mongolian gerbils (highly resistant to atherosclerosis) and their sucklings (first generation) were randomly assigned to two groups of 5 couples each (group 1: basal diet; group 2: 8.75% w/w PO in diet). In the second generation parameters such as frequency of litters, number of pups, mean litter size, mean weight, postnatal mortality were observed.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
Glycerides, C8-18, C18-unsatd.
IUPAC Name:
Glycerides, C8-18, C18-unsatd.
Constituent 2
Chemical structure
Reference substance name:
Glycerides, C8-18 and C18-unsatd.
EC Number:
266-946-3
EC Name:
Glycerides, C8-18 and C18-unsatd.
Cas Number:
67701-28-4
Molecular formula:
Triglycerides containing a glycerol backbone esterified to fatty acids with a carbon chain length of C8-18 as well as unsaturated C18 fatty acids
IUPAC Name:
Tri(C8-18 and C18-unsatd. fatty acyl)glycerol
Details on test material:
- Name of test material (as cited in study report): Palm kernel oil (CAS N° 8023-79-8, EC N° 232-425-4). Under the SDA nomenclature, the name of this substance is 'Glycerides, C8-18 and C18-unsatd.'

Test animals

Species:
other: gerbil
Strain:
other: Mongolian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Adult gerbils and their sucklings (F1) were used at the initiation
- Housing: Housed in couples in standard laboratory cages with a wire mesh lid with food hopper. The bedding consisted of wood shavings.
- Diet (e.g. ad libitum): Diets manufactured by Hope Farms BV (Woerden, The Netherlands) were used. The test diet contained increased protein (26 %), biotin, choline, inositol and vitamin E (50 %) and, cellulose (1 %).
- Water (e.g. ad libitum): Water acidified with HCI (pH 3), ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 %
- Photoperiod: 10 hrs light/14 hrs dark

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on exposure:
No data
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
Not applicable
Details on mating procedure:
No data
Duration of treatment / exposure:
2 generations (specific period not mentioned)
Frequency of treatment:
Daily
Duration of test:
Up to 6 months of F2 generation
Doses / concentrations
Remarks:
Doses / Concentrations:
8.75% w/w
Basis:
nominal in diet
No. of animals per sex per dose:
5 couples per group
Control animals:
yes, plain diet
Details on study design:
No data

Examinations

Maternal examinations:
No data
Ovaries and uterine content:
Not examined
Fetal examinations:
The following parameters were examined in [F2] offspring: Frequency of litters, number of pups, mean litter size, mean weight at 6 months of age andpostnatal mortality

Statistics:
The Student-t test for unpaired samples was used to compare the variables of the different groups. For large differences in variance between the samples, the Wilcoxon test for unpaired samples was used. p < 0.05 was considered significant.
Indices:
Litter frequency: calculated by dividing the total number of weeks during which the couples of gerbils within one dietary group were able to breed by the number of litters
Historical control data:
No data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no data

Details on maternal toxic effects:
Not applicable

Effect levels (maternal animals)

Dose descriptor:
NOAEC
Effect level:
> 8.75 other: % w/w
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:not examined

Details on embryotoxic / teratogenic effects:
Not applicable

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

OFFSPRING PARAMETERS:

 

BODY WEIGHT (OFFSPRING): No significant difference compared to controls was observed (F1 and F2)

FREQUENCY OF LITTERS (F2): No significant effects were observed.


NUMBER OF PUPS (F2): No significant difference was observed (PO: 116 and basal diet (control): 146).


MEAN LITTER SIZE (F2): No significant difference was observed (PO: 4.7±1.7 and basal diet (control): 4.9±1.6).


POSTNATAL MORTALITY (F2): No significant mortality was observed in comparison to basal diet group ( PO: 4 % and basal diet (control): 3 %)

Applicant's summary and conclusion

Conclusions:
Based on the results, a NOAEC of 8.57% w/w can be considered for F2 generation (developmental effects) for palm kernel oil.
Executive summary:

A two generation reproductive toxicity study was conducted in Mongolian gerbils to assess the effect of the palm kernel oil (PO).

Adult Mongolian gerbils (highly resistant to atherosclerosis) and their sucklings (first generation) were randomly assigned to two groups of 5 couples each (group 1: basal diet; group 2: 8.75% w/w PO in diet). In the second generation parameters such as frequency of litters, number of pups, mean litter size, mean weight, postnatal mortality were observed.

 

No significant effect on frequency of litters, mean litter size, total no. of newborns, mean body weight and no postnatal mortality were found in the second generation of the fed group compared to the basal dietary group.

 

Based on the results, a NOAEC of 8.57% w/w can be considered for F2 generation (developmental effects) for palm kernel oil.